FDA Issues New Guidance on Decentralized Clinical Trials

Updated document builds on pandemic-era considerations for conducting DCTs

The Food and Drug Administration released new draft guidance May 1 for conducting decentralized clinical trials (DCTs) for drugs, biologics, and medical devices.

The agency's proposal outlines recommendations for sponsors, investigators, and other stakeholders of clinical trials that take place partly or entirely outside traditional clinical trial sites. Examples include scheduling clinical follow-up visits using telemedicine and performing laboratory tests at a local facility in place of the clinical research site.

The draft document builds on agency recommendations issued in December 2021 during the COVID-19 pandemic, when FDA released initial guidance as DCTs experienced rapid adoption. The additional guidance released this week provides clarification around planning, documentation, and execution of specific DCT features.

Although the regulatory requirements are the same for DCTs as traditional site-based clinical trials, the new recommendations address considerations specific to DCTs, such as:

• Design considerations for a DCT
• Conducting remote clinical trial visits and other clinical trial-related activities
• Using digital health technologies to acquire data remotely
• Roles and responsibilities of the sponsor and investigators
• Obtaining informed consent and institutional review board oversight of the process
• Determination of the appropriateness of investigational products
• Packaging and shipping of investigational products
• Safety monitoring of trial participants

FDA added that DCTs can reduce barriers to participation, increase the breadth and diversity of clinical trial participants, and boost access for those with mobility challenges.

DCTs have been recognized for their many benefits — particularly the ability to increase diversity in clinical trials as well as reach populations, such as rare disease populations, that can be difficult to access in traditional clinical trial settings by reducing barriers to and burdens of participation. The recent guidance signals FDA's continued commitment to supporting use of DCTs.

In a statement, FDA Commissioner Robert M. Califf, M.D., said, "As we seek to improve our evidence generation system, decentralized clinical trials may enhance convenience for trial participants, reduce the burden on caregivers, expand access to more diverse populations, improve trial efficiencies, and facilitate research on rare diseases and diseases affecting populations with limited mobility."

FDA will accept public comments on the draft guidance through August 1, 2023.